Method and system for providing integrated analyte monitoring and infusion system therapy management

ABSTRACT

Method and system for providing diabetes management and insulin therapy based on substantially real time glucose monitoring system is provided.

BACKGROUND

With increasing use of pump therapy for Type 1 diabetic patients, youngand old alike, the importance of controlling the infusion device such asexternal infusion pumps is evident. Indeed, presently available externalinfusion devices typically include an input mechanism such as buttonsthrough which the patient may program and control the infusion device.Such infusion devices also typically include a user interface such as adisplay which is configured to display information relevant to thepatient's infusion progress, status of the various components of theinfusion device, as well as other programmable information such aspatient specific basal profiles.

The external infusion devices are typically connected to an infusion setwhich includes a cannula that is placed transcutaneously through theskin of the patient to infuse a select dosage of insulin based on theinfusion device's programmed basal rates or any other infusion rates asprescribed by the patient's doctor. Generally, the patient is able tocontrol the pump to administer additional doses of insulin during thecourse of wearing and operating the infusion device such as for,administering a carbohydrate bolus prior to a meal. Certain infusiondevices include food database that has associated therewith, an amountof carbohydrate, so that the patient may better estimate the level ofinsulin dosage needed for, for example, calculating a bolus amount.

However, in general, most estimation or calculation of a bolus amountfor administration, or a determination of a suitable basal profile, forthat matter, are educated estimates based on the patient's physiology asdetermined by the patient's doctor, or an estimate performed by thepatient. Moreover, the infusion devices do not generally includeenhancement features that would better assist the diabetic patients tocontrol and/or manage the glucose levels.

In view of the foregoing, it would be desirable to have a method andsystem for providing insulin therapy determination and recommendationbased on real time monitored analyte levels of the patient for proactiveinsulin therapy treatment to improve management of diabetes.

SUMMARY OF THE INVENTION

In accordance with the various embodiments of the present invention,there are provided method and system for receiving data associated withmonitored analyte related levels for a predetermined time periodsubstantially in real time, retrieving one or more therapy profilesassociated with the monitored analyte related levels, generating one ormore modifications to the retrieved one or more therapy profiles basedon the data associated with the monitored analyte related levels.

These and other objects, features and advantages of the presentinvention will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating a therapy management system forpracticing one embodiment of the present invention;

FIG. 2 is a block diagram of a fluid delivery device of FIG. 1 in oneembodiment of the present invention;

FIG. 3 is a flow chart illustrating therapy management procedure basedon real time monitored analyte levels in accordance with one embodimentof the present invention;

FIG. 4 is a flowchart illustrating analyte trend information updatingprocedure based on real time monitored analyte levels in accordance withone embodiment of the present invention; and

FIG. 5 is a flowchart illustrating modified therapy management procedurebased on real time monitored analyte levels in accordance with oneembodiment of the present invention.

DETAILED DESCRIPTION

As described in detail below, in accordance with the various embodimentsof the present invention, there are provided various embodiments forproviding real time or substantially real time monitored levelsassociated with a patient's analyte levels, and one or more associatedtherapy recommendation associated with the monitored analyte levels toprovide real time insulin therapy and management. Accordingly, in oneembodiment of the present invention, diabetic patients may bettercontrol the glucose levels and improve their physiological conditionsbased on accurate and substantially real time monitoring of glucoselevels, and are provided with one or more recommendations for modifyingor maintaining the insulin therapy (based on, for example, insulin pumptherapy), for real time proactive management of glucose levels.

FIG. 1 is a block diagram illustrating an insulin therapy managementsystem for practicing one embodiment of the present invention. Referringto FIG. 1, the therapy management system 100 includes an analytemonitoring system 110 operatively coupled to an fluid delivery device120, which may be in turn, operatively coupled to a remote terminal 140.As shown in the Figure, the analyte monitoring system 110 is, in oneembodiment, coupled to the patient 130 so as to monitor or measure theanalyte levels of the patient. Moreover, the fluid delivery device 120is coupled to the patient using, for example, an infusion set and tubingconnected to a cannula (not shown) that is placed transcutaneouslythrough the skin of the patient so as to infuse medication such as, forexample, insulin, to the patient.

Referring to FIG. 1, in one embodiment the analyte monitoring system 110in one embodiment may include one or more analyte sensors subcutaneouslypositioned such that at least a portion of the analyte sensors aremaintained in fluid contact with the patient's analytes. The analytesensors may include, but are not limited to short term subcutaneousanalyte sensors or transdermal analyte sensors, for example, which areconfigured to detect analyte levels of a patient over a predeterminedtime period, and after which, a replacement of the sensors is necessary.

The one or more analyte sensors of the analyte monitoring system 110 iscoupled to a respective one or more of a data transmitter unit which isconfigured to receive one or more signals from the respective analytesensors corresponding to the detected analyte levels of the patient, andto transmit the information corresponding to the detected analyte levelsto a receiver device, and/or fluid delivery device 120. That is, over acommunication link, the transmitter units may be configured to transmitdata associated with the detected analyte levels periodically, and/orintermittently and repeatedly to one or more other devices such as theinsulin delivery device and/or the remote terminal 140 for further dataprocessing and analysis.

The transmitter units of the analyte monitoring system 110 may in oneembodiment, configured to transmit the analyte related datasubstantially in real time to the fluid delivery device 120 and/or theremote terminal 140 after receiving it from the corresponding analytesensors such that the analyte level such as glucose level of the patient130 may be monitored in real time. In one aspect, the analyte levels ofthe patient may be obtained using one or more discrete blood glucosetesting devices such as blood glucose meters, or a continuous analytemonitoring systems such as continuous glucose monitoring systems.

Additional analytes that may be monitored, determined or detected theanalyte monitoring system 110 include, for example, acetyl choline,amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase(e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined.

Moreover, within the scope of the present invention, the transmitterunits of the analyte monitoring system 110 may be configured to directlycommunicate with one or more of the remote terminal 140 or the fluiddelivery device 120. Furthermore, within the scope of the presentinvention, additional devices may be provided for communication in theanalyte monitoring system 110 including additional receiver/dataprocessing unit, remote terminals (such as a physician's terminal and/ora bedside terminal in a hospital environment, for example. In addition,within the scope of the present invention, one or more of the analytemonitoring system 110, the fluid delivery device 120 and the remoteterminal 140 may be configured to communicate over a wireless datacommunication link such as, but not limited to a radio frequency (RF)communication link, Bluetooth® communication link, infraredcommunication link, or any other type of suitable wireless communicationconnection between two or more electronic devices, which may further beunidirectional or bi-directional communication between the two or moredevices. Alternatively, the data communication link may include wiredcable connection such as, for example, but not limited to RS232connection, USB connection, or serial cable connection.

Referring back to FIG. 1, in one embodiment, the analyte monitoringsystem 110 includes a strip port configured to receive a test strip forcapillary blood glucose testing. In one aspect, the glucose levelmeasured using the test strip may in addition, be configured to provideperiodic calibration of the analyte sensors of the analyte monitoringsystem 110 to assure and improve the accuracy of the analyte levelsdetected by the analyte sensors.

Additional detailed description of the continuous analyte monitoringsystem, its various components including the functional descriptions ofthe sensor, transmitter unit, receiver unit, and remote terminal/dataprocessing terminal are provided in U.S. Pat. No. 6,175,752 issued Jan.16, 2001 entitled “Analyte Monitoring Device and Methods of Use”, and inapplication Ser. No. 10/745,878 filed Dec. 26, 2003 entitled “ContinuousGlucose Monitoring System and Methods of Use”, each assigned to theAssignee of the present application.

Referring again to FIG. 1, the fluid delivery device 120 may include inone embodiment, but not limited to, an external infusion device such asan external insulin infusion pump, an implantable pump, a pen-typeinsulin injector device, an on-body patch pump, an inhalable infusiondevice for nasal insulin delivery, or any other type of suitabledelivery system. In addition, the remote terminal 140 in one embodimentmay include for example, a desktop computer terminal, a datacommunication enabled kiosk, a laptop computer, a handheld computingdevice such as a personal digital assistant (PDAs), or a datacommunication enabled mobile telephone.

FIG. 2 is a block diagram of an insulin delivery device of FIG. 1 in oneembodiment of the present invention. Referring to FIG. 2, the fluiddelivery device 120 in one embodiment includes a processor 210operatively coupled to a memory unit 240, an input unit 220, a displayunit 230, an output unit 260, and a fluid delivery unit 250. In oneembodiment, the processor 210 includes a microprocessor that isconfigured to and capable of controlling the functions of the fluiddelivery device 120 by controlling and/or accessing each of the variouscomponents of the fluid delivery device 120. In one embodiment, multipleprocessors may be provided as a safety measure and to provide redundancyin case of a single processor failure. Moreover, processing capabilitiesmay be shared between multiple processor units within the insulindelivery device 120 such that pump functions and/or control may beperformed faster and more accurately.

Referring back to FIG. 2, the input unit 220 operatively coupled to theprocessor 210 may include a jog dial, a key pad buttons, a touch padscreen, or any other suitable input mechanism for providing inputcommands to the fluid delivery device 120. More specifically, in case ofa jog dial input device, or a touch pad screen, for example, the patientor user of the fluid delivery device 120 will manipulate the respectivejog dial or touch pad in conjunction with the display unit 230 whichperforms as both a data input and output units. The display unit 230 mayinclude a touch sensitive screen, an LCD screen, or any other types ofsuitable display unit for the fluid delivery device 120 that isconfigured to display alphanumeric data as well as pictorial informationsuch as icons associated with one or more predefined states of the fluiddelivery device 120, or graphical representation of data such as trendcharts and graphs associated with the insulin infusion rates, trend dataof monitored glucose levels over a period of time, or textualnotification to the patients.

Referring to FIG. 2, the output unit 260 operatively coupled to theprocessor 210 may include audible alarm including one or more tonesand/or preprogrammed or programmable tunes or audio clips, or vibratoryalert features having one or more pre-programmed or programmablevibratory alert levels. In one embodiment, the vibratory alert may alsoassist in priming the infusion tubing to minimize the potential for airor other undesirable material in the infusion tubing. Also shown in FIG.2 is the fluid delivery unit 250 which is operatively coupled to theprocessor 210 and configured to deliver the insulin doses or amounts tothe patient from the insulin reservoir or any other types of suitablecontainment for insulin to be delivered (not shown) in the fluiddelivery device 120 via an infusion set coupled to a subcutaneouslypositioned cannula under the skin of the patient.

Referring yet again to FIG. 2, the memory unit 240 may include one ormore of a random access memory (RAM), read only memory (ROM), or anyother types of data storage units that is configured to store data aswell as program instructions for access by the processor 210 andexecution to control the fluid delivery device 120 and/or to performdata processing based on data received from the analyte monitoringsystem 110, the remote terminal 140, the patient 130 or any other datainput source.

FIG. 3 is a flow chart illustrating insulin therapy management procedurebased on real time monitored analyte levels in accordance with oneembodiment of the present invention. Referring to FIG. 3, in oneembodiment of the present invention, a predetermined number ofconsecutive glucose levels are received or detected over a predeterminedor defined time period. For example, in one embodiment, referring toFIG. 1, the monitored glucose levels of a patient is substantiallycontinuously received or detected substantially in real time for apredetermined time period. In one embodiment, the predefined time periodmay include one or more time periods, the data within which may providea therapeutically meaningful basis for associated data analysis.

That is, the predefined time period of the real time monitored glucosedata in one embodiment may include one or more time periods sufficientto provide glucose trend information or sufficient to provide analysisof glucose levels to adjust insulin therapy on an on-going, andsubstantially real time basis. For example, the predefined time periodin one embodiment may include one or more of a 30 minute time period, a30 minute time period, a 45 minute time period, a one hour time period,a two hour time period and a 6 hour time period. While exemplarypredefined time periods are provided herein, within the scope of thepresent invention, any suitable predefined time period may be employedas may be sufficient to be used for glucose trend determination and/ortherapy related determinations (such as, for example, modification ofexisting basal profiles, calculation of temporary basal profile, ordetermination of a bolus amount).

Referring back to FIG. 3, the consecutive glucose levels received overthe predefined time period in one embodiment may not be entirelyconsecutive due to, for example, data transmission errors and/or one ormore of potential failure modes associated with data transmission orprocessing. As such, in one embodiment of the present invention, thereis provided a predetermined margin of error for the received real timeglucose data such that, a given number of data points associated withglucose levels which are erroneous or alternatively, not received fromthe glucose sensor, may be ignored or discarded.

Referring back to FIG. 3, upon receiving the predetermined number ofglucose levels over a predefined time period, the glucose trendinformation based on the received glucose levels is updated. Forexample, in one embodiment, the glucose trend information estimating therate of change of the glucose levels may be determined, and based uponwhich the projected level of glucose may be calculated. Indeed, in oneembodiment, the glucose trend information may be configured to provideextrapolated glucose level information associated with the glucose levelmovement based on the real time glucose data received from the glucosesensor. That is, in one embodiment, the real time glucose levelsmonitored are used to determine the rate at which the glucose levels iseither increasing or decreasing (or remaining substantially stable at agiven level). Based on such information and over a predetermined timeperiod, a glucose projected information may be determined.

Referring again to FIG. 3, the therapy related parameters associatedwith the monitored real time glucose levels is updated. That is, in oneembodiment, one or more insulin therapy related parameters of an insulinpump such as including, but not limited to, insulin on board informationassociated with the fluid delivery device 120 (FIG. 1), insulinsensitivity level of the patient 130 (FIG. 1), insulin to carbohydrateratio, and insulin absorption rate. Thereafter, in one embodiment, oneor more modifications to the current therapy profile are determined.That is, in one embodiment of the present invention, one or more currentbasal profiles, calculated bolus levels, temporary basal profiles,and/or any other suitable pre-programmed insulin delivery profilesstored in the fluid delivery device 120 (FIG. 1) for example, areretrieved and analyzed based on one or more of the received real timeglucose levels, the updated glucose trend information, and the updatedtherapy related parameters.

Referring back to FIG. 3, after determining one or more modifications tothe therapy profiles, the modified one or more therapy profiles isgenerated and output to the patient 130 (FIG. 1) so that the patient 130may select, store and/or ignore the one or more modified therapyprofiles based on one or more of the monitored real time glucose values,updated glucose trend information, and updated therapy relatedparameters.

For example, in one embodiment, the patient 130 may be provided with arecommended temporary basal profile based on the monitored real timeglucose levels over a predetermined time period as well as the currentbasal profile which is executed by the fluid delivery device 120(FIG. 1) to deliver a predetermined level of insulin to the patient 130(FIG. 1). Alternatively, the patient 130 in a further embodiment may beprovided with one or more additional recommended actions for selectionas the patient sees suitable to enhance the insulin therapy based on thereal time monitored glucose levels. For example, the patient may beprovided with a recommended correction bolus level based on the realtime monitored glucose levels and the current basal profile inconjunction with, for example, the patient's insulin sensitivity and/orinsulin on board information.

In this manner, in one embodiment of the present invention, based onreal time monitored glucose levels, the patient may be provided with anon-going, real time insulin therapy options and modifications to thepre-programmed insulin delivery basal profiles so as to improve upon theinitially programmed therapy profiles based on the monitored real timeglucose data.

FIG. 4 is a flowchart illustrating analyte trend information updatingprocedure based on real time monitored analyte levels in accordance withone embodiment of the present invention. Referring to FIG. 4, in oneembodiment, real time data associated with monitored analyte levels isreceived. Thereafter it is determined whether the real time data hasbeen received for a predetermined time period. If it is determined thatthe real time data has not been received for at least the predeterminedtime period, then the routine continues to receive the real time dataassociated with the monitored analyte levels such as glucose levels.

On the other hand, referring back to FIG. 4, if it is determined thatthe real time data associated with the monitored analyte levels havebeen received for the predetermined time period (for example, asdescribed above in conjunction with FIG. 3), then, the received realtime data associated with the monitored analyte levels is stored.Thereafter, analyte level trend information is determined based on thereceived real time data associated with the monitored analyte levels.

For example, in one embodiment, the real time data associated with themonitored analyte levels is analyzed and an extrapolation of the databased on the rate of change of the monitored analyte levels isdetermined. That is, the real time data associated with the monitoredanalyte levels is used to determined the rate at which the monitoredanalyte level changed over the predetermined time period, andaccordingly, a trend information is determined based on, for example,the determined rate at which the monitored analyte level changed overthe predetermined time period.

In a further embodiment, the trend information based on the real timedata associated with the monitored analyte levels may be dynamicallymodified and continuously updated based on the received real time dataassociated with the monitored analyte levels for one or morepredetermined time periods. As such, in one embodiment, the trendinformation may be configured to dynamically change and be updatedcontinuously based on the received real time data associated with themonitored analyte levels.

FIG. 5 is a flowchart illustrating modified therapy management procedurebased on real time monitored analyte levels in accordance with oneembodiment of the present invention. Referring to FIG. 5, in oneembodiment, the current therapy parameters are retrieved and, theretrieved current therapy parameters are analyzed based on the receivedreal time data associated with the monitored analyte levels and/orupdated analyte trend information. For example, one or morepreprogrammed basal profiles, correction bolus, carbohydrate bolus,temporary basal and associated parameters are retrieved and analyzedbased on, for example, the received real time data associated with themonitored analyte levels and/or updated analyte trend information, andfurther, factoring in the insulin sensitivity of the patient as well asinsulin on board information.

Referring to FIG. 5, based upon the analysis of the current therapyparameters, one or more modified therapy profiles are calculated. Thatis, based upon the real time glucose levels monitored by the analytemonitoring system 110 (FIG. 1), a modification or adjustment to thepre-programmed basal profiles of the fluid delivery device 120 (FIG. 1)may be determined, and the modified therapy profiles is output to thepatient 130 (FIG. 1). That is, the modification or adjustment to thepre-programmed basal profiles may be provided to the patient for reviewand/or execution to implement the recommended modification or adjustmentto the pre-programmed basal profiles.

In this manner, the patient may be provided with one or more adjustmentsto the existing or current basal profiles or any other pre-programmedtherapy profiles based on continuously monitored physiological levels ofthe patient such as analyte levels of the patient. Indeed, in oneembodiment of the present invention, using continuously monitoredglucose levels of the patient, modification or adjustment to thepre-programmed basal profiles may be calculated and provided to thepatient for review and implementation as desired by the patient. In thismanner, for example, a diabetic patient may improve the insulin therapymanagement and control.

Within the scope of the present invention, the processes and routinesdescribed in conjunction with FIGS. 3-5 may be performed by the analytemonitoring system 110 (FIG. 1) and/or the fluid delivery device 120(FIG. 1). Furthermore, the output of information associated with themodified therapy parameters, trend information, and/or real time dataassociated with the monitored analyte levels may be displayed on adisplay unit of the receiver of the analyte monitoring system 110 (FIG.1), or the infusion device display of the fluid delivery device 120(FIG. 1) or both. Alternatively, one or more such information may beoutput to the patient audibly as sound signal output.

In this manner, in accordance with the various embodiments of thepresent invention, there are provided methods and system for providinginformation associated with the direction and rate of change of analyte(e.g., glucose) levels changes for determination of, for example, bolusor basal rate change recommendations, for comparing expected glucoselevel changes to actual real time glucose level changes to update, forexample, insulin sensitivity factor in an ongoing basis, and forautomatically confirming the monitored glucose values within a presettime period (e.g., 30 minutes) after insulin therapy initiation todetermine whether the initiated therapy is having the intendedtherapeutic effect.

Indeed, in accordance with the various embodiments of the presentinvention, the use of glucose trend information in insulin delivery ratedeterminations provides for a more accurate insulin dosing and may leadto a decrease in hypoglycemic events and improved HbA1Cs.

Accordingly, a method in one embodiment of the present inventionincludes receiving data associated with monitored analyte related levelsfor a predetermined time period substantially in real time, retrievingone or more therapy profiles associated with the monitored analyterelated levels, generating one or more modifications to the retrievedone or more therapy profiles based on the data associated with themonitored analyte related levels.

The method may further include displaying the generated one or moremodifications to the retrieved one or more therapy profiles.

In one aspect, the generated one or more modifications to the retrievedone or more therapy profiles may be displayed as one or more of analphanumeric output display, a graphical output display, an icondisplay, a video output display, a color display or an illuminationdisplay.

In a further aspect, the predetermined time period may include a timeperiod between 15 minutes and six hours.

The one or more therapy profiles in yet another aspect may include abasal profile, a correction bolus, a temporary basal profile, an insulinsensitivity, an insulin on board level, and an insulin absorption rate.

In still another aspect, retrieving the one or more therapy profilesassociated with the monitored analyte related levels may includeretrieving a current analyte rate of change information.

In yet still another aspect, generating the one or more modifications tothe retrieved one or more therapy profiles may include determining amodified analyte rate of change information based on the received dataassociated with monitored analyte related levels.

Moreover, the method may further include generating an output alertbased on the modified analyte rate of change information.

Still, the method may also include determining an analyte levelprojection information based on the modified analyte rate of changeinformation.

A system for providing diabetes management in accordance with anotherembodiment of the present invention includes an interface unit, one ormore processors coupled to the interface unit, a memory for storinginstructions which, when executed by the one or more processors, causesthe one or more processors to receive data associated with monitoredanalyte related levels for a predetermined time period substantially inreal time, retrieve one or more therapy profiles associated with themonitored analyte related levels, and generate one or more modificationsto the retrieved one or more therapy profiles based on the dataassociated with the monitored analyte related levels.

The interface unit may include an input unit and an output unit, theinput unit configured to receive the one or more analyte related data,and the output unit configured to output the one or more of thegenerated modifications to the retrieved one or more therapy profiles.

The interface unit and the one or more processors in a furtherembodiment may be operatively coupled to one or more of a housing of aninfusion device or a housing of an analyte monitoring system.

The infusion device may include one of an external insulin pump, animplantable insulin pump, an on-body patch pump, a pen-type injectiondevice, an inhalable insulin delivery system, and a transdermal insulindelivery system.

The memory in a further aspect may be configured for storinginstructions which, when executed by the one or more processors, causesthe one or more processors to display the generated one or moremodifications to the retrieved one or more therapy profiles.

Further, the memory may be configured for storing instructions which,when executed by the one or more processors, causes the one or moreprocessors to display the generated one or more modifications to theretrieved one or more therapy profiles as one or more of an alphanumericoutput display, a graphical output display, an icon display, a videooutput display, a color display or an illumination display.

In one aspect, the predetermined time period may include one of a timeperiod between 15 minutes and six hours.

The one or more therapy profiles may include a basal profile, acorrection bolus, a temporary basal profile, an insulin sensitivity, aninsulin on board level, and an insulin absorption rate.

In another aspect, the memory may be further configured for storinginstructions which, when executed by the one or more processors, causesthe one or more processors to retrieve a current analyte rate of changeinformation.

In still another aspect, the memory may be further configured forstoring instructions which, when executed by the one or more processors,causes the one or more processors to determine a modified analyte rateof change information based on the received data associated withmonitored analyte related levels.

Additionally, in yet still another aspect, the memory may be furtherconfigured for storing instructions which, when executed by the one ormore processors, causes the one or more processors to generate an outputalert based on the modified analyte rate of change information.

Further, the memory may be further configured for storing instructionswhich, when executed by the one or more processors, causes the one ormore processors to determine an analyte level projection informationbased on the modified analyte rate of change information.

A system for providing diabetes management in accordance with yetanother embodiment of the present invention includes an analytemonitoring system configured to monitor analyte related levels of apatient substantially in real time, a medication delivery unitoperatively for wirelessly receiving data associated with the monitoredanalyte level of the patient substantially in real time from the analytemonitoring system, a data processing unit operatively coupled to the oneor more of the analyte monitoring system or the medication deliveryunit, the data processing unit configured to retrieve one or moretherapy profiles associated with the monitored analyte related levels,and generate one or more modifications to the retrieved one or moretherapy profiles based on the data associated with the monitored analyterelated levels.

In one aspect, the analyte monitoring system may be configured towirelessly communicate with the medication delivery unit over a radiofrequency (RF) communication link, a Bluetooth® communication link, anInfrared communication link, or a local area network (LAN).

The various processes described above including the processes performedby the processor 210 in the software application execution environmentin the fluid delivery device 120 as well as any other suitable orsimilar processing units embodied in the analyte monitoring system 110and the remote terminal 140, including the processes and routinesdescribed in conjunction with FIGS. 3-6, may be embodied as computerprograms developed using an object oriented language that allows themodeling of complex systems with modular objects to create abstractionsthat are representative of real world, physical objects and theirinterrelationships. The software required to carry out the inventiveprocess, which may be stored in the memory unit 240 (or similar storagedevices in the analyte monitoring system 110 and the remote terminal140) of the processor 210, may be developed by a person of ordinaryskill in the art and may include one or more computer program products.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1. A method, comprising: receiving, at a medical device, data associatedwith monitored glucose related levels measured by a glucose sensor for afirst predetermined time period substantially in real time, the medicaldevice having a processor unit; retrieving, using the processor unit,one or more therapy profiles associated with the monitored glucoserelated levels; determining, using the processor unit, a rate of changeof the monitored glucose related levels for the first predetermined timeperiod; extrapolating, using the processor unit, a projected glucoserelated level based on the monitored glucose related levels and thedetermined rate of change of the monitored glucose related levels;comparing, using the processor unit, the projected glucose related levelwith a corresponding -monitored glucose related level; confirming, usingthe processor unit, the monitored glucose related levels within a secondpredetermined time period after insulin therapy initiation, based atleast in part on the comparison of the projected glucose related levelwith the corresponding monitored glucose related level, to determinewhether the insulin therapy is having an intended therapeutic effect;generating, using the processor unit, one or more modifications to theretrieved one or more therapy profiles based on the data associated withthe monitored glucose related levels, and updating, using the processorunit, an insulin sensitivity factor on an ongoing basis based at leastin part on the comparison of the projected glucose related level withthe corresponding monitored glucose related level.
 2. The method ofclaim 1 further including displaying, on a display, the generated one ormore modifications to the retrieved one or more therapy profiles.
 3. Themethod of claim 2 wherein the generated one or more modifications to theretrieved one or more therapy profiles is displayed as one or more of analphanumeric output display, a graphical output display, an icondisplay, a video output display, a color display or an illuminationdisplay.
 4. The method of claim 1 wherein the first predetermined timeperiod includes a time period between 15 minutes and six hours.
 5. Themethod of claim 1 wherein the one or more therapy profiles includes abasal profile, a correction bolus, a temporary basal profile, an insulinsensitivity, an insulin on board level, and an insulin absorption rate.6. The method of claim 1 wherein retrieving, using the processor unit,one or more therapy profiles associated with the monitored glucoserelated levels includes retrieving a current glucose rate of changeinformation.
 7. The method of claim 6 wherein generating, using theprocessor unit, one or more modifications to the retrieved one or moretherapy profiles includes determining a modified glucose rate of changeinformation based on the received data associated with monitored glucoserelated levels.
 8. The method of claim 7 further including generating,using the processor unit, an output alert based on the modified glucoserate of change information.
 9. The method of claim 7 further includingdetermining, using the processor unit, an glucose level projectioninformation based on the modified glucose rate of change information.10. The method of claim 1, wherein a first predetermined number ofmonitored glucose related levels are received over the firstpredetermined time period.
 11. The method of claim 10, furthercomprising discarding, using the processor unit, up to a secondpredetermined number of monitored glucose related levels in the firstpredetermined time period, wherein the second predetermined number isbased on a predetermined margin of error.
 12. The method of claim 11,wherein the first predetermined number equals a total number ofmonitored glucose related levels measured by the glucose sensor in thefirst predetermined time period less the second predetermined number.13. A system for providing diabetes management, comprising: an interfaceunit; one or more processors coupled to the interface unit; and a memorystoring instructions which, when executed by the one or more processors,causes the one or more processors to receive data associated withmonitored glucose related levels for a predetermined time periodsubstantially in real time, retrieve one or more therapy profilesassociated with the monitored glucose related levels, determine a rateof change of the monitored glucose related levels for the predeterminedtime period, extrapolate a projected glucose related level based on themonitored glucose related levels and the determined rate of change ofthe monitored glucose related levels, compare the projected glucoserelated level with a corresponding monitored glucose related level,confirm automatically the monitored glucose related levels within asecond predetermined time period after insulin therapy initiation, basedat least in part on the comparison of the projected glucose relatedlevel with the corresponding monitored glucose related level, todetermine whether the insulin therapy is having an intended therapeuticeffect, generate one or more modifications to the retrieved one or moretherapy profiles based on the data associated with the monitored glucoserelated levels, and update an insulin sensitivity factor on an ongoingbasis based at least in part on the comparison of the projected glucoserelated level with the corresponding monitored glucose related level.14. The system of claim 13 wherein the memory further storesinstructions which, when executed by the one or more processors, causesthe one or more processors to display the generated one or moremodifications to the retrieved one or more therapy profiles.
 15. Thesystem of claim 14 wherein when the memory further stores instructionswhich, when executed by the one or more processors, causes the one ormore processors to display the generated one or more modifications tothe retrieved one or more therapy profiles as one or more of analphanumeric output display, a graphical output display, an icondisplay, a video output display, a color display or an illuminationdisplay.
 16. The system of claim 13 wherein the predetermined timeperiod includes one of a time period between 15 minutes and six hours.17. The system of claim 13 wherein the one or more therapy profilesincludes a basal profile, a correction bolus, a temporary basal profile,an insulin sensitivity, an insulin on board level, and an insulinabsorption rate.
 18. The system of claim 13 wherein the memory furtherstores instructions which, when executed by the one or more processors,causes the one or more processors to retrieve a current glucose rate ofchange information.
 19. The system of claim 18 wherein the memoryfurther stores instructions which, when executed by the one or moreprocessors, causes the one or more processors to determine a modifiedglucose rate of change information based on the received data associatedwith monitored glucose related levels.
 20. The system of claim 19wherein the memory further stores instructions which, when executed bythe one or more processors, causes the one or more processors togenerate an output alert based on the modified glucose rate of changeinformation.
 21. The system of claim 19 wherein the memory furtherstores instructions which, when executed by the one or more processors,causes the one or more processors to determine a glucose levelprojection information based on the modified glucose rate of changeinformation.
 22. The system of claim 13 wherein the interface unitincludes an input unit and an output unit, the input unit configured toreceive the one or more glucose related data, and the output unitconfigured to output the one or more of the generated modifications tothe retrieved one or more therapy profiles.
 23. The system of claim 13wherein the interface unit and the one or more processors areoperatively coupled to one or more of a housing of an infusion device ora housing of an glucose monitoring system.
 24. The system of claim 23wherein the infusion device includes an external insulin pump.